Temozolomide in Treating Patients With Low-Grade Glioma
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|ClinicalTrials.gov Identifier: NCT00313729|
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : January 23, 2019
Last Update Posted : February 7, 2019
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with supratentorial low-grade glioma.
|Condition or disease||Intervention/treatment||Phase|
|CNS Tumor, Adult||Drug: temozolomide||Phase 2|
- Determine the efficacy of temozolomide, defined as response rate (complete and partial response), in patients with supratentorial mixed low-grade glioma.
- Assess the safety profile of temozolomide in patients with supratentorial low-grade glioma.
- Assess the time to tumor progression in patients treated with temozolomide.
OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Temozolomide (TEMODAR) in the Treatment of Adult Patients With Supratentorial Low Grade Glioma|
|Study Start Date :||May 1999|
|Actual Primary Completion Date :||September 25, 2014|
|Actual Study Completion Date :||June 12, 2017|
Other Name: Temodar
- Response Rate (Complete and Partial Response) [ Time Frame: 12 months ]Assessment of treatment response was determined by MRI in conjunction with neurological examination and steroid requirement assessment derived from Macdonald's criteria. Complete response was defined as complete disappearance of lesion on consecutive MRI scans with stable or improved neuro exam and steroids. Partial response was defined as a 50% reduction in lesion size or that tumor burden was "definitely better" than prior scan with stable or improved neuro exam and steroids.
- Time to Tumor Progression [ Time Frame: time from registration until date of the first documented progression, an average of 1 year ]Progressive disease was defined as definite enlargement of any existing lesion or any new lesion based on modified Macdonald's criteria.
- Safety Profile [ Time Frame: Time from registration up to 13 months ]Number of participants with treatment related grade 2-4 adverse events as defined by CTCAE 3.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313729
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|Study Chair:||Susan M. Chang, MD||University of California, San Francisco|